I vividly recall my first excursion into the world of human anatomy. I was sitting around a table with my family playing Operation, a popular board game where the players pretend to be surgeons. Even if you are not a surgeon or have never worked in the medical profession, chances are that you have been compelled or inspired to learn about the human body. If so, then you know that our bodies are complex. For example, the adult human skeletal system alone has 206 bones. Moreover, depending on the specific system of function in question, there may be dozens, hundreds, or thousands of different body parts that share that same classification.
Why and How Are Electronic Medical Devices Classified?
The FDA classifies medical devices based on their usage and potential harm. The reason for this is to protect users and patients from any adverse outcomes. The FDA defines a medical device as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which…” can be described by one of the following:
- Is listed in the National Formulary or the United States Pharmacopoeia. This includes any supplemental material.
- Was developed to prevent, diagnose or treat disease in people or animals.
- Is formulated or finalized external to the body, but is used to impact the function or structure of the body.
This definition does not include drugs and omits software that may be used in support of the device. It is also important to note that an accessory here means a finished product that is essential for a finished parent device to fulfill its primary function. Optional devices that may be used with a parent device do not typically meet the requirements of this definition.
The FDA does not formally distinguish between electronic and other medical devices for the purposes of assigning devices to class 1, 2, or 3. However, the FDA does regulate the recordkeeping and reporting of devices that emit radiation under 21 CFR 1000 - 1299. This is a separate regulatory requirement from FCC Title 47. The FDA also provides guidance as to what constitutes an electronic product [device] under section 531 of the Food, Drug and Cosmetics (FD&C) Act. Specifically, an electronic product is:
- Any product that is or is a part of an electronic circuit, and
- Emits radiation (even if that radiation is shielded), or
- Any “article” that is a part of an electronic circuit and emits radiation (even is that radiation is shielded).
Instead, if your electronic device is used for medical purposes, it is subject to regulation as both an emitter of radiation and as a medical device.
Once you have established that your device is an electronic medical device, you can follow the steps below to ensure the proper classification is made.
Step 1: Determine if your device type is already classified
There are two ways to do this. The more general approach is to search the 16 specialty panels. This will help you to hone in on the best type for your device. Alternatively, you can do a direct search of the product database.
Step 2: If your device type is classified
In most cases, your device type will already be listed. If so, then you will need to follow the requirements for that device type. For example, if the device is class 1 or class 2, it may be exempt from premarket notification or 510(k) submission. However, if it is class 3, premarket approval (PMA) may be required.
NOTE: The fact that your device is classified only specifies which classification requirements you need to follow. It does not alleviate any of those requirements.
In addition to the premarket requirements above, all medical devices, including electronic, must adhere to the registration, labeling, and quality management good manufacturing practices (GMPs) provisions.
PCBA Manufacturing for Extreme Environments - Part 1
Step 3: If your device type is not classified
In the rare case that your device does not match a listed type or you cannot determine whether your product is a medical device, you can contact the FDA for guidance at:
Center’s Device Determination Officers,
Office of Compliance,
Following the procedures for classifying your electronic medical devices can seem like a maze of directives that is difficult to navigate. However, making the proper determination is imperative because your device may otherwise never make it to market. Moreover, the classification requirements may negatively impact your development process. Regardless of the specific class your device falls under, you need a well-qualified and certified partner to build your boards. Tempo Automation is experienced in providing high-quality boards for the medical industry and is IPC-13485 certified.
|Tempo's Advanced Custom PCB Manufacturing Service for Complex Medical Systems Development
We will get started on the best path by furnishing information for your DFM checks and enable you to easily view and download DRC files. If you’re an Altium Designer or Cadence Allegro user, you can simply add these files to your PCB design software. For Mentor Pads or other design packages, we furnish DRC information in other CAD formats and Excel.
If you are ready to have your design manufactured, try our quote tool to upload your CAD and BOM files. If you want more information on developing and classifying electronic medical devices, contact us.